Talk:Protocols

Introduction

The purpose of this page is to collect and share protocols, based on best practices, for a variety of NMR-related activities.

Sample Preparation

1. Procedure 1 here

Spectrometer Calibrations

1. Procedure 1 here

Spectrometer Validation

1. Procedure 1 here

NMR Method Development

1. Procedure 1 here

NMR Method Validation

1. Procedure 1 here

Analytical Method Validation References: Guidance Documents

1. Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration.
2. <1225> Validation of Compendial Procedures. United States Pharmacopeia
3. <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopeia
4. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonization
5. Guide to NMR Method Development and Validation - Part I: Identification and Quantification; EUROLAB Technical Report No. 01/2014.
6. Guide to NMR Method Development and Validation - Part II: Multivariate Data Analysis; EUROLAB Technical Report No. 01/2015.
7. Validation of Test Methods - General Principles and Concepts. EUROLAB, 1996.
8. JP
9. JIS
10. ASTM